Results for “Orthopaedic Osteotomes”

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Registry EUDAMED 201 FDA 510(k) incl. De Novo FDA PMA GUDID 2

Country / market European Union (all) 201 United States 2

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Germany 187 Belgium 14

Risk class Class I 201 Class IIa Class IIb Class III Class II (US)

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Class A Class B Class C Class D IVD General IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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Orthopaedic osteotomes, reusable

Amnotec International Medical GmbH,Germany Group of variants

Active Regimes: CE MDD Registry: EUDAMED Class:I
Orthopädische Osteotome, wiederverwendbar

Amnotec International Medical GmbH,Germany Group of variants

Active Regimes: CE MDD Registry: EUDAMED Class:I

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Results for “Orthopaedic Osteotomes”

Category (EMDN)

Orthopaedic osteotomes, reusable

Orthopädische Osteotome, wiederverwendbar